Melissa Kaufman, MD, PhD, Patricia and Rodes Hart Endowed Chair in Urologic Surgery, Professor of Urology and Chief of the Division of Reconstructive Urology and Pelvic Health talks about a new technology, called InterStim, that can aid in bladder control.
Interview conducted by Ivanhoe Broadcast News in 2022.
What is InterStim? How is it different from other treatments for incontinence?
DR KAUFMAN: The way to really begin the conversation is understanding more about what we’re trying to treat, which is a condition called overactive bladder. Overactive bladder is basically a collection of symptoms that a person can experience. It’s really characterized by urinary urgency. That urgency is a sudden and compelling desire to urinate that just can’t be deferred. It is often associated with urinary frequency, and sometimes that means also frequent urinations at nighttime, as well as an occasional leakage of urine that is accompanied by those urges. Now, there are a number of different conditions that can provoke these symptoms, and very rarely are these issues something to worry about. But it doesn’t mean that they shouldn’t be addressed. Sometimes these symptoms are associated with aging, hormone loss, or prior pelvic surgeries. But even something as subtle as back strain can manifest in these types of overactive bladder symptoms. However, overactive bladder is not expected. It’s not a normal part of aging. And although it’s not anticipated, it is exceedingly common. It is estimated that there are 37 million Americans with this condition. That’s one in six Americans. That makes it more common than diabetes and more common than high blood pressure. So, what you can expect when you come to a urologist, or your primary care physician, is an open conversation about what’s happening. What we find is that many patients are very reticent to discuss this because it’s an intimate and very delicate condition, but that’s why we’re here. We’re here to help because we have very meaningful and very accessible therapies for overactive bladder. The beginnings of that conversation may just entail understanding more about what type of symptoms you’re encountering. It may include a physical exam and a simple urine test before we can start to develop a treatment strategy that’s going to work for that individual. There are, certainly, behavioral therapies that can provide exceptional benefit, modification of diet, modification of lifestyle, and modification of fluid intake that may significantly change a patient’s symptoms. Many patients will benefit from pharmaceutical therapies. There is a subset of patients that require more advanced therapies, and that’s where technologies, like neuromodulation or the InterStim, come in. It is fundamentally a pacemaker system that helps reregulate these abnormal signals to the bladder that result in the overactive bladder symptoms. It is a minimally invasive outpatient procedure that can allow patients to understand whether they’re going to benefit from it before they undergo a full implant.
You mentioned before that lifestyle changes can improve bladder control before medication. What kind of lifestyle changes can people try first to see if that could help?
DR KAUFMAN: What we have discovered is that there are numerous different things that patients can do in their own day-to-day activities that can change their bladder symptoms, and some of those do involve the types of fluids that they intake, whether they’re caffeinated, acidic, or alcoholic. All these things impact storage of that urine in the bladder that can provoke these symptoms. There are also things from the diet that can impact the bladder symptoms. Tomato products, because of their acidity, may increase the symptoms of overactive bladder, but other things that may not be quite as obvious include exercise. We know, for a broad range of different types of leakage for both men and women, that exercise can really impact how the body reacts and the strength of the pelvic muscles that allow them to gain some resolution for their leakage.
How does the science and technology of InterStim help treat symptoms?
DR KAUFMAN: For patients who have not responded to lifestyle changes, who have not responded to pharmaceutical agents that are directed at the way that the bladder stores and empties urine, the InterStim helps deflect the abnormal signaling that occurs. There’s been some insult to the nerve supply that’s leading into the bladder and the signaling that’s coming out of the bladder that’s disrupting the natural pathway that allows urine to be held passively. It’s provoking these symptoms of urgency to have to go. Sometimes, the bladder is contracting on its own against the patient’s will for it to happen. The InterStim implant allows this nerve signaling, from the bladder and to the bladder, to be modified. It can suppress some aspects that are abnormal and escalate some that have caused other issues like urinary retention where people have difficulty urinating. It treats a wide variety of pelvic floor disorders by disrupting abnormal signaling and helping abnormal signaling. Now, this also includes urgency leakage, frequency, retention of urine, but also bowel leakage, which is a very troublesome problem that patients are extraordinarily reluctant to seek care for their bowel issues because it is a very delicate and intimate condition.
Can you talk a little bit about the InterStim’s rechargeable battery?
DR KAUFMAN: Yes. For many decades now, since we’ve had this technology out since the late 1990s in utilization for bladder conditions, we’ve had a singular way to deliver energy to the lead wire, which is providing the electrical signaling. It was an implanted battery. Over time, with all technology, it’s undergoing modifications and iterations that have miniaturized the device. Now, we have a very small profile device that’s smaller than a typical USB thumb drive and it has a rechargeable capacity. So, patients can weekly or monthly place a recharger on a belt and wear it for half an hour in order to prolong the battery life. Typically, with the implanted battery, we can still enjoy a five-year lifespan for the battery before it needs replacement. But this new rechargeable device gives us, on average, 15 years of time before it would need a replacement. It’s significantly changed how we counsel individuals in their options that are available. We have many patients that still choose to have a non-rechargeable device if it doesn’t fit their lifestyle. But because patients are so facile nowadays and agile with recharging all their other electronic devices, it made sense. It also is one of the technologies that’s used in other types of neuromodulation systems such as cardiac pacemakers.
Who would be an ideal patient for this?
DR KAUFMAN: The ideal patient is the individual who’s really engaged in their own wellness, who is someone who wants to move forward with their life without having the worry of their bladder constantly at their side. It can help individuals who have been tremendously impacted and debilitated by these symptoms explore new avenues of their lives and get back to the things that they enjoyed. The patient who is an excellent candidate is someone that we’ve gone through the process together with. That we have made a shared decision that this technology is going to be the best option for them and that they’ve demonstrated during a test phase that it works for them. So, once they’ve made that decision, they’re the ones who tell me that they’re the best candidate for the InterStim because they’ve demonstrated that it’s efficacious for themselves.
Are there any patients that InterStim wouldn’t be ideal for?
DR KAUFMAN: There are patients who may have a higher risk profile for implant of any type of medical device. We need to think about this as if we’re considering implant of any type of device, such as an artificial knee or an artificial hip. And there are some patients that are higher risk for those types of implants.
What would make them higher risk?
DR KAUFMAN: So, sometimes there are other medical conditions or other medications that they’re taking. We would work through that in a very individual fashion with a patient. But being at an institution like Vanderbilt, we often approach these with a multidisciplinary team that includes my colleagues from anesthesia, from cardiology. We make sure that we’re doing the safest thing for the patient before we embark upon this therapy.
Can you talk to me about Dr. Linda Brice’s case?
DR KAUFMAN: Yeah. So, Dr. Brice was completely debilitated from a personal and professional sense when she came to me. Her urinary leakage had progressed to a point where she was unable to do the things that she loved, including teaching nursing classes. So, she was so tied to the bathroom that she was mapping the bathroom everywhere she went. She was wearing very heavy pads and diapers, daytime and nighttime. We went through the entire process together. When she chose to undergo the implant, she had a great deal of enthusiasm and optimism because she had done a lot of very sophisticated reading, as you might expect from a nursing professor, about the device itself. It worked magically for her. It really transformed the way that she went about her life. Dr. Brice and I walked through all the different options for treatment, and it turned out that the InterStim was the one that she felt was going to give her the most durable response over a long period of time. The battery timing turned out to be wonderful for her because when the battery finally needed a replacement, we had the opportunity for her to switch to a rechargeable device, which she has relished having the opportunity to keep for long periods of time.
She was telling us that she had five different surgeries just to switch out all the different implants. Is that right?
DR KAUFMAN: Yeah. Some patients, over time, will undergo several different minimally invasive procedures in order to change components. But it is an iterative process, meaning that once the device is implanted, we do a lot of sophisticated programming and working with the patient in the clinic to optimize the therapy for their biology and for their condition.
After someone has this implanted, are there any restrictions? How long does it take for them to feel relief from their symptoms?
DR KAUFMAN: Well, they’ll feel relief during the first week. Oftentimes, when we do the test phase, there’s one week in between two outpatient minimally invasive procedures. They’ll know during that time period that the device is working for them and relieving their symptoms. So, it’s almost immediate. Once you recover from the surgery itself, you’ll begin to see effect, immediately. Overall, the recovery requires no heavy lifting or strenuous activity for several weeks after the procedures. But it is very easy surgery to recover from in general. And patients do well with very minimal need for any type of pain medications.
Is there anything else you feel is important for people to know?
DR KAUFMAN: One of the most profound things that I want the audience to know is that there are passionate, and compassionate, providers out there who want to help you through this very troublesome and debilitating time. You should ask for a referral to a urologist in order to discuss these issues. We’re here to help improve your quality of life. And although these are quality of life conditions, they are not benign. They can have a tremendous impact. We can work together to help move you forward and put this part behind you.
Any known side effects or adverse events once it’s implanted?
DR KAUFMAN: Very seldom do patients have abnormal sensations. Most of the time, we can move the stimulation around. With some patients, there’s always risk to any surgical procedure, including infection, bleeding, those types of things that in the vast majority of cases are very well controlled, so a minimally invasive procedure for maximal benefit for your quality of life.
END OF INTERVIEW
This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.
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